Can Nicotine be Used Medicinally in Parkinson's Disease?

Claire Thiriez; Gabriel Villafane; Frédérique Grapin; Gilles Fenelon; Philippe Remy; Pierre Cesaro

Disclosures

Expert Rev Clin Pharmacol. 2011;4(4):429-436. 

In This Article

Ongoing Studies

The Nicopark2 study (Table 3) is ongoing in 40 advanced PD patients randomized in two groups: 'transdermal nicotine' and 'best medical management'. The primary end point is the change of Unified Parkinson's Disease Rating Scale motor scores recorded after 28 weeks of treatment at the highest dose of nicotine by standardized video and evaluated by blinded central review. The secondary end points are: the evolution of motor and cognitive symptoms, the total daily dose of antiparkinsonian treatment, the quality of life and the progression of dopaminergic cell loss measured using dopamine transporter imaging with SPECT.[56] Patients are followed over 1 year. One important feature of this trial is the duration of administration of a high dose of nicotine (total 38 weeks, maximum 90 mg/day). Raters will assess the Unified Parkinson's Disease Rating Scale motor score at the end of the protocol and will be blinded to treatment group, the time of the video recording and the 'off' or 'on' L-DOPA status. One of the blinded investigators will assess the primary objective (improvement of motor score in 'off' conditions), while another will evaluate the dose–response relationship and the motor effect at week 39. The third blinded examiner will compare the motor status in both groups 5 weeks after nicotine tapering. To date, 72% of the targeted cohort has been included already.

Another study has included a cohort of 60 advanced PD patients: 'Study of NP002 in Subjects With Idiopathic PD to Treat Dyskinesias Due to Levodopa Therapy'. This trial is the only other recruiting advanced PD patients. Oral capsules containing placebo/nicotine are administered during 10 weeks, with moderate doses (maximum 24 mg/day). This double-blind, randomized, parallel-group study is designed to establish if doses that can be tolerated by Parkinsonian patients will also reduce the severity and frequency of L-DOPA-induced dyskinesias.

A third double-blind randomized study is designed to examine whether treatment with low doses of transdermal nicotine improves computer-based laboratory and clinical measures of impulsive and compulsive behavior in PD subjects. This pilot trial will evaluate a 3 weeks treatment duration with a cross-over design in 60 PD subjects who have recently experienced an impulse control disorder.

The last controlled trial is sponsored by the Michael J Fox Foundation and will be launched to demonstrate a neuroprotective effect of transdermal nicotine. Approximately 150 PD patients will be enrolled in this multicenter (20 sites) trial. Patients will be randomly assigned to receive either nicotine patches or placebo patches over a treatment period of 12 months in a double-blinded manner. The trial should start soon, but authors of the paper do not know the dose of transdermal nicotine used in this trial.

Overall, we can conclude that there is no agreement at this time about the optimal dose of nicotine, the duration of the treatment and the various goals of these trials.

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